Sterile technique tube end closure and syringe adaptor

ABSTRACT

A tube end closure for medicosurgical tube devices having an encircling removal cap that is captive to the closure body is molded as an integral unit from plastic material. The closure is constructed to make fluidtight union with tapered connectors of Luer syringes. A syringe needle penetratable plug may be fixed inside the closure sufficiently below the proximal end tip so contact of the plug will occur only with a syringe needle when fluids are injected or withdrawn via the closure.

United States Patent 3,477,438 11/1969 Allen et al. 128/349 BV 2,896,629 7/1959 Warr 128/349 B 3,467,103 9/1969 McKinstry et al. 128/349 B 2,884,151 4/1959 Biederman 215/99 X 3,219,036 11/1965 Stafford 128/348 X 2,690,861 10/1954 Tupper 215/99 UX Primary Examiner Dalton L. Truluck Attorney-Kemon, Palmer & Estabrook ABSTRACT: A tube end closure for medicosurgical tube devices having an encircling removal cap that is captive to the closure body is molded as an integral unit from plastic material. The closure is constructed to make fluidtight union with tapered connectors of Luer syringes. A syringe needle penetratable plug may be fixed inside the closure sufficiently below the proximal end tip so contact of the plug will occur only with a syringe needle when fluids are injected or withdrawn via the closure.

STERILE TECHNIQUE TUBE END CLOSURE AND SYRINGE ADAPTOR BACKGROUND OF THE INVENTION This invention relates to end closures for medicosurgical tube devices which serve not only to maintain sterile conditions in the handling and use of the devices, but also as adapters for operatively connecting a syringe to the medicosurgical tube device as may be required for injection or withdrawal of fluids through the device.

Devices in he form of tubes involving a distal end which is inserted into a patient and a proximal end through which fluids may be introduced or withdrawn in the treatment of a patient are made in a variety of forms. Some of these are called catheters, e.g., suction catheters, Foley catheters, urethral catheters, thoracic catheters, and the like. In other cases, the devices are referred to as cannulae, e.g., nasal oxygen cannulae, intravenous cannulae, etc. Additionally, the devices are referred to as tubes, e.g., stomach tubes, feeding tubes, rectal tubes, flush tubes, endotracheal tubes, and the like. This invention is contemplated for use with all such devices where an end closure for sterile technique procedures is necessary or desirable. The term medicosurgical tube is used throughout the following description and claims as a general term to encompass all such devices whether they be referred to as catheters, cannulae, or tubes.

It is essential when any medicosurgical tube device is first inserted into a patient for required treatment or operation, that the device be in completely sterile condition. With such devices that are reused a number of times, sterilization may be accomplished by autoclaving or by immersion in sterilizing solution. Sometimes such procedure fails to completely sterilize the medicosurgical tube device and cross infection occurs in the use of a single device upon multiple patients. In order to avoid this, as well as expense of onsite sterilization with rising labor costs, the present trend is to use medicosurgical tube devices which are designed and constructed for disposal after use upon a single patient. Improvements of the present invention are contemplated for use on both these general classes of devices, but they are particularly advantageous with regard to medicosurgical tube devices of the disposable type.

In many types of medical or surgical procedures, once a sterile medicosurgical tube device has been inserted in a patient, the proximal end will be attached to some auxiliary equipment so that the device is sealed ofi from the ambient atmosphere and sterile conditions throughout the interior of the tube device are maintained until the treatment is terminated and the tube device withdrawn from the patient. On the other hand, there are a number of medicosurgical tube devices which by their nature and method of use permit or require the proximal end to be intermittently exposed to the ambient atmosphere, handled by a person attending the patient, contacted by a syringe or other piece outside equipment or the like. One example of this is feeding tubes for the nasogastric feeding of both infant and adult patients. Such feeding tubes, once inserted in the patient, remain in position for extended periods of time although feeding liquids will be introduced through them into the patient only at spaced intervals. During the periods of nonuse, it is desirable that the proximal end of the feeding tube be closed to prevent ingress of bacteria.

A somewhat different example of medicosurgical tubes which have a proximal end element that in the course of treatment of a patient receives intermittent use are endotracheal tubes. Normally these involve a balloon cuff which is inflated by a secondary side tube in order to retain the endotracheal tube within the patient during administration of anesthesia or other fluids through the principal lumen in treatment of the patient. With such devices, it becomes necessary to introduce air or liquid through the secondary tube to inflate the balloon cuff and this is normally accomplished using a syringe to inject the fluid and apply the pressure required to inflate the cufi. This may need to be repeated several times during a given operation on a patient. Hence, it is desirable that such tubes be provided with a syringe adapter which enables a syringe to be quickly and easily applied and then withdrawn as required in the particular circumstances.

Various schemes have been used in closing ends of medicosurgical tubes during intermittent use as described or for adapting syringes to the tube structures for whatever purpose this would be required. For example, rubber plugs of stoppers have been used to close tube proximal ends. Also, funnelshaped caps have been used for this purpose. Funnel-shaped ends have also been employed as connectors or adapters for syringes to medicosurgical tube devices. However, notwithstanding the various schemes or structures used heretofore, there is need for improvement in end closures and syringe adapters employed with medicosurgical tube devices, particularly from the viewpoint of maintaining sterile conditions throughout use of the device in treatment of patients and also in the simplicity and ease with which the tube device may be adapted to a syringe or otherwise manipulated as may be required by the treatment being applied to the patient.

OBJECTS A principal object of this invention is the provision of new forms of sterile technique tube end closures and syringe adapters for medicosurgical tube devices. Further objects include be injected or withdrawn, which element is protected against contamination during handling and use of the device.

3. New end closures for medicosurgical tubes with captive removable caps that are highly effective and easily manipulated in sterile technique use of the device.

Other objects and further scope of applicability of the present invention will become apparent from the detailed described given hereinafter; it should be understood, however, the the detailed description, while indicating preferred embodiments of the invention, is given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

SUMMARY OF THE INVENTION These objects are accomplished according to the present invention by the provision of sterile technique tube end closures and syringe adapters for medicosurgical tube devices which comprise a distal end portion, a proximal end portion, a central body portion, a removable cap for said proximal end portion and fastener strip through which said cap is held captive to said central body portion, all of said portions and strip being molded of plastic material as an integral unit. The proximal end portion is preferably of larger diameter than said distal end portion of said central body portion is tapered from said proximal end to said distal end. Further, the removal cap comprises a cylinder portion of inside diameter approximately equal to the outside diameter of said proximal end portion, a transverse top and a central plug depending concentrically inside said cylinder portion from said top and said plug has an outside diameter approximately equal to the inside diameter of said proximal end. Further, the end closure includes an encircling removable cap that is captive to the closure body, the body and cap being cylindrical in shape.

Advantageously, the new tube end closures of the invention are molded from semirigid or rigid polyvinyl chloride material although they may be molded from any other suitable plastic of elastomeric material such as synthetic rubber, polyolefins, acrylic resins, or the like.

As a preferred embodiment of the invention, there are provided feeding tubes equipped on the proximal end with a tube end closure having a structure as aforesaid. As another preferred embodiment, there are endotracheal tubes having a balloon cuff which is inflatable through a secondary lumen and inflation tube, the proximal end of the inflation tube being equipped with a tube end closure and syringe adapter of the invention constructed as aforesaid.

Objects of the invention are further accomplished through the provision of end closures for medicosurgical tube devices that comprise a plug of elastomeric material which is penetratable by a syringe needle and will automatically reseal upon withdrawal of the syringe needle, such plug being positioned distally of the proximal end tip of the closure sufficiently so that contact of the plug will occur only with the syringe needle when the end closure is handled by a person attending the patient on which the medicosurgical tube device with the end closure is associated. Preferably, the needle penetratable plug is positioned a distance below the proximal end of the closure at least twice the diameter of the proximal end portion.

BRIEF DESCRIPTION OF THE DRAWINGS For a more detailed understanding of the invention, reference is made to the accompanying drawings in which:

FIG. 1 is a perspective view on an endotracheal tube having an inflation tube for the balloon cuifequipped with and end closure and syringe adapter in accordance with the invention.

FIG. 2 is a fragmentary side view partially in section of the end closure and syringe adapter shown in FIG. 1 with the cap removed and a Luer syringe inserted in the adapter.

FIG. 3 is an enlarged sectional view of the end closure and syringe adapter of FIG. 1 with the encircling cap in place.

FIG. 4 is an enlarged sectional side view similar to FIG. 3 showing an alternative form of end closure and syringe adapter in accordance with the invention.

FIG. 5 is an enlarged end view of the cap for the end closure looking into the cap.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring in detail to the drawings, and end closure and syringe adapter 2 for medicosurgical tube devices, such as endrotracheal tube 4 in accordance with the invention, comprises a distal end portion 6, a proximal end portion 8, a central body portion 10, and a removable cap 12. The removable cap is made captive to the closure body by a fastener strip 14 which is molded as an integral unit from plastic material with the cap and the closure body (see FIG. 3).

The proximal end portion 8 is of larger diameter than the distal end portion 6 and the central body portion is tapered beginning at the base 16 of the proximal end portion downwardly to its connection 18 with the base of the distal end portion 6.

In the preferred embodiment of the invention as shown in FIG. 1, the endotracheal tube 4 has an inflatable balloon cuff 20, a secondary lumen 22, and an inflation tube 24 joined to the proximal end 26 of the secondary lumen through which the balloon cuff may be inflated via the secondary lumen. The tube end closure 2 of the invention is fixed to the proximal end 28 of the inflation tube 24. Advantageously, the material of which the end closure 2 is molded is semirigid polyvinyl chloride material which may be formulated to be transparent or translucent, but which is preferably pigmented to be opaque. The endotracheal tube 4 is fabricated initially by extrusion of tubing sections from plasticized polyvinyl chloride material and assembled by suitable procedures. Endotracheal tubes or other medicosurgical tubes to which the new tube closure and syringe adapters of the invention are applied may take any form desired known to the art.

The end closure 2 may be fixed to the inflation tube 24 at the proximal end 28 or to any other medicosurgical tube device to which it may be connected with cement or adhesive, by friction welding, by induction welding, or in any other manner known to the plastic art for joining together two elements of plastic material, The junction between the medicosurgical tube and the end closure may be an overlapped joint such as shown in FIG. 3, a butt joint (not shown) or shiplap joint (not shown).

The removable cap 12 comprises an outside cylinder portion 30 having an inside diameter approximately equal to the outside diameter of the proximal end portion 8 of the closure 2, a transverse top 32 and a central plug 34 depending concentrically inside the cylinder portion 30 downwardly from the top 32. Said plug 34 has an outside diameter approximately equal to the inside diameter of the proximal end 8 of the closure 2.

When the removable cap is in place upon the proximal end of the closure (see FIG. 3), the cap encircles the closure end protecting both the outside and inside of the closure from contamination. In addition to this protective feature of the encircling form of cap, the cap may be easily manipulated for removal by one hand of the person attending the patient upon which the medicosurgical tube device is being used. Moreover, the central plug 34 of the cap 12 serves to maintain cylindrical shape in the closure body, thereby aiding in the cap removal as required and also improving the cap sealing function.

The closure 2 has the proximal end 8 of such size as to make a fluidtight union (see FIG. 2) with the male connector 40 of a Luer syringe 42. Hence, manipulation of the plunger 44 of the syringe will give the required suction or pressure for withdrawal or injection of liquids or other fluids through the closure 2 into the attached tube 24. Such use of a syringe can be for inflating a balloon cuff 20 of an endotracheal tube, introducing feeding liquid into a feeding tube, removing or injecting fluids through a catheter, or for any other purposes as required by the operation being performed upon the patient.

' In a preferred embodiment of the new tube closures as shown in FIG. 4, the central body portion 10 of the closure 2 is plugged with a section 46 of soft elastomeric material that may be penetrated by a syringe needle and will reseal upon withdrawal of the syringe needle. Resealable elastomeric compositions of this type are known in the art. Such resealable section is utilized in unique manner in accordance with the invention to improve on sterile techniques in use of medicosurgical tube devices. Thus, the top surface 48 of the elastomeric section or plug 46 is sufiiciently below the proximal end tip 50 of the closure 2 so that accidental contact of the top surface 48 of the plug 46 with any outside substance or member is substantially prevented, i.e., contact will only be made intentionally such as with a syringe needle and contact with the finger of the arty using the device will be prevented. Advantageously, this is attained by making the combined length of the proximal end portion 8 and central body portion 10 of the closure 2 at least twice the diameter of the proximal end portion 8 and the top surface 48 of the elastomeric plug 46 is below the tip 50 of the proximal end portion 8 a distance at least equal to the inside diameter of the proximal end portion 8.

The embodiments of the invention in which an exclusive property or right is claimed are defined as follows:

1. An endotracheal tube comprising an inflatable balloon cuff, a secondary lumen and an inflation tube joined to the proximal end of the secondary lumen through which the balloon cuff may be inflated via the secondary lumen, a tube end closure fixed to the proximal end of said inflation tube, said end closure comprising a distal end portion, a proximal end portion, a central body portion, a removal cap for said proximal end portion and fastener strip through which said cap is tied to said central body portion, all of said portions and strip being molded of plastic material as an integral unit, said proximal end portion being of larger diameter than said distal end portion, said central body portion being tapered from said proximal end to said distal end, said removal cap comprising a cylinder portion of inside diameter approximately equal to the outside diameter of said proximal end portion, a transverse top and a central plug depending concentrically inside said cylinder portion from said top, said plug having an outside diameter approximately equal to the inside diameter of said proximal end, said plug being shorter in length than said cylinder portion whereby the free end of said plug is recessed within said cylinder portion, and a plug fixed within said tapered central body portion of the end closure made of soft 5 elastomeric material that may be penetrated by a syringe nee dle and will reseal upon withdrawal of the syringe needle. 

1. An endotracheal tube comprising an inflatable balloon cuff, a secondary lumen and an inflation tube joined to the proximal end of the secondary lumen through which the balloon cuff may be inflated via the secondary lumen, a tube end closure fixed to the proximal end of said inflation tube, said end closure comprising a distal end portion, a proximal end portion, a central body portion, a removal cap for said proximal end portion and fastener strip through which said cap is tied to said central body portion, all of said portions and strip being molded of plastic material as an integral unit, said proximal end portion being of larger diameter than said distal end portion, said central body portion being tapered from said proximal end to said distal end, said removal cap comprising a cylinder portion of inside diameter approximately equal to the outside diameter of said proximal end portion, a transverse top and a central plug depending concentrically inside said cylinder portion from said top, said plug having an outside diameter approximately equal to the inside diameter of said proximal end, said plug being shorter in length than said cylinder portion whereby the free end of said plug is recessed within said cylinder portion, and a plug fixed within said tapered central body portion of the end closure made of soft elastomeric material that may be penetrated by a syringe needle and will reseal upon withdrawal of the syringe needle. 